ACTiF- Assessment of Closed Tibial Fractures

• Drug: CP-533, 536
  
  Active study drug
• Drug: Placebo
  
  Placebo vehicle
• Procedure: Standard of Care
  
  Standard surgical procedure
• Drug: CP-533,536
  
  Active study drug

• Experimental: CP-533,536 Dose Level 2
  
  Intervention: Drug: CP-533, 536
• Placebo Comparator: Placebo
  
  Intervention: Drug: Placebo
• Standard of Care
  
  Intervention: Procedure: Standard of Care
• Experimental: CP-533,536 Dose Level 1
  
  Intervention: Drug: CP-533,536
• Experimental: CP-533,536 Dose Level 3
  
  Intervention: Drug: CP-533,536
• Experimental: CP-533.536 Dose Level 4
  
  Intervention: Drug: CP-533,536

Inclusion Criteria:

• Males or females 17 years or older with confirmed closure of the tibial epiphyses, with a closed fracture of the tibial diaphysis undergoing treatment with reamed locked IM nailing procedure and the absence of an associated compartment syndrome or vascular injury;
• Closed tibial fractures Types A, B & C (See OTA fracture classification) can be included.

Exclusion Criteria:

• Previous fractures of the same tibia that may impact nailing procedure or impaired visibility of current fracture or a history of osteomyelitis;
• Subjects with any other clinically significant injuries, which may significantly impair weight bearing of the affected limb;
• Subjects with a fracture gap of >1cm after initial surgery and prior to drug administration;
• Any other planned invasive or non invasive interventions intended to promote bone healing of the tibial fracture under study are not allowed in the first 24 weeks after treatment.